ong-Term Safety Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Phase 3
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2009/091/000501
- Lead Sponsor
- Phenomix Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)
Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301
Exclusion Criteria
?Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
?Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate safety and tolerability of dutogliptin.Timepoint:
- Secondary Outcome Measures
Name Time Method To demonstrate maintenance or lowering of HbA1c.<br><br>To demonstrate maintenance or lowering of fasting blood glucose.<br>Timepoint: